Baseline Characteristics and Recruitment in a Randomised Trial of Community Vs Hospital Direct Acting Antiviral Treatment for Hepatitis C

Author: Wade AJ, Doyle JS, Thompson AJ, Hellard ME on behalf of the Prime Study Group

Theme: Clinical Research Year: 2016


Wade AJ1,4, Doyle JS1,2,3, Thompson AJ3,6, Hellard ME1,2,4 on behalf of the Prime Study Group

1Centre for Population Health, Burnet Institute, 2Department of Infectious Diseases, The Alfred, 3Department of Medicine, University of Melbourne, 4School of Population Health and Preventive Medicine, Monash University, 5Department of Gastroenterology, St Vincent’s Hospital, Melbourne.

Background: The Prime Study is the first real-world, randomized, model of care study, comparing direct acting antiviral (DAA) hepatitis C treatment uptake and outcomes in the community with a tertiary hospital. Community based care has the potential to substantially increase treatment uptake and reduce the burden of disease. We describe the baseline characteristics of the first 60 participants recruited at Primary Health care service (PHCS) by community hepatitis nurses. A high proportion of PHCS clients have a history of injecting drug use.

Methods: Eligible patients were those with genotype 1 hepatitis C mono-infection, who were not known to be cirrhotic and did not have concomitant medication interactions with Viekira Pak and ribavirin. Patients were randomized to undergo a FibroScan and receive DAA therapy in their community PHCS (intervention arm) or the local tertiary hospital (standard of care arm). FibroScan assessment and treatment at the PHCS was provided by a community hepatitis nurse, with support from a general practitioner.

Results: 61 participants have been screened and randomized. Median age at screening was 45 years (range 33 – 65) and 45 (74%) were male. 54 (89%) had completed high school, whilst 17 (28%) were employed or studying and 7 (11%) had unstable housing. Only 5 (8%) participants had previously received treatment for HCV. 59 (97%) participants reported injecting in the past, 26 (43%) had injected in the last 6 months and 36 (59%) were on opioid substitution therapy. 25 participants have had FibroScan results reported, median 6.8 kPa (range 3.1 – 17.8).

Conclusions: Treatment of people who inject drugs has the duel benefit of curing their HCV and reducing ongoing HCV transmission. Key will be to increase the number undergoing treatment. Community based care is likely to increase HCV treatment accessibility and uptake in this priority population.

Disclosure of interest statement: “The Prime Study is an investigator driven study sponsored by AbbVie. The investigators recognise the need for transparency of disclosure of potential conflicts of interest and acknowledging these relationships in publications and presentations.”

Download abstract